Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for adults who are having shoulder surgery to see if Epidiolex helps with pain. Participants will keep a pain diary, fill out surveys, and have blood tests after surgery.
Are You a Good Fit for This Trial?
Must not be takingValproateClobazam
You may be able to join if
I am over 18 years old
I am having rotator cuff repair surgery
I will receive standard anesthesia for my surgery
If I can become pregnant, I am using effective contraception
You may not be able to join if
I am under 18 years old
I have a history of liver disease
I am currently taking narcotics
I have a history of substance abuse
I have recently used marijuana or cannabidiol
I am pregnant or breastfeeding
I have a psychiatric disorder
I have not treated my sleeping disorder
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.
Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.
Participants will:
* track their pain and what …
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.
Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.
Participants will:
* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.
* Complete two short surveys. Once before surgery and once after.
* Have bloodwork tested after surgery
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Above the age of 18 years old
* Undergoing a rotator cuff repair surgery
* Receiving standard anesthesia during surgery
* If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.
E…
Inclusion Criteria:
* Above the age of 18 years old
* Undergoing a rotator cuff repair surgery
* Receiving standard anesthesia during surgery
* If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.
Exclusion Criteria:
* Under the age of 18 years old
* History of revision shoulder arthroplasty
* History of liver disease or impairment
* Are currently taking valproate or clobazam
* Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor
* Are currently taking a strong CYP3A4 or CYP2C19 inducer
* Are currently taking narcotics
* History of substance/alcohol abuse
* Those currently or previously under the care of a pain management specialist
* History of marijuana/cannabidiol (not including topical) regular use within the past 6 months
* Allergy related to cannabidiol
* Allergy related to sesame seeds
* Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
* If you are taking any medications with known risks for suicidal behavior and ideation
* If you have a diagnosed psychiatric disorder
* If you are untreated for a diagnosed sleeping disorder
* If you are actively breastfeeding
* Patients currently taking central nervous system (CNS) depressants
* Patients currently taking other drugs with known hepatotoxicity
* Vulnerable populations.
Patients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.
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